Boston Scientific defibrillator alert

Saturday

Mar 28, 2009 at 6:00 AM

By Alex Nussbaum BLOOMBERG NEWS

Boston Scientific Corp., which has operations in Marlboro, said the company’s Cognis and Teligen defibrillators, surgically implanted devices used to treat abnormal heartbeats, may deliver unneeded shocks to patients, or fail when shocks are needed.

The malfunction occurred at least 15 times and may be a problem in as many as 8,000 patients who use a respiratory sensor on the devices, the Natick-based company told doctors in a March 23 letter. The letter said wires that are used to connect the defibrillators to the heart were malfunctioning. No deaths have been reported, the company said.

Cognis and Teligen, introduced in May, are among the products Chief Executive Officer James Tobin has said will help Boston Scientific spur growth and move the company beyond a series of safety recalls since 2006. The company letter said the latest risk can be eliminated by switching off the respiratory sensors, which track a patient’s breathing.

“More than anything, I think doctors and patients want to be assured that Boston Scientific is delivering top-notch stuff,” said Christopher Warren, a Caris & Co. analyst in New York, in a telephone interview. “Any time something like this comes out it shakes confidence in not just one company but the industry as a whole.”

Boston Scientific spokesman Paul Donovan confirmed the letter had gone out to doctors and said the company had contacted regulatory authorities. It has no plans to recall devices or pull them from sale, he said in an e-mail. The respiratory sensor can be switched off wirelessly, Donovan said.

Shares of Boston Scientific fell 37 cents, or 4.3 percent, to $8.20 at 4 p.m. yesterday in New York Stock Exchange composite trading.

Problems with the wires “may cause additional oversensing, thereby increasing the probability of inappropriate therapy,” the letter said. “Five to eight successive inappropriate shocks could leave the device unable to treat” an actual heartbeat problem, the letter said. Boston Scientific has sold 34,000 Cognis and Teligen devices, he said.

The defibrillators are among the “major products” Boston Scientific has introduced over the past year that will help it grab sales from rivals, Tobin said at a March 17 conference.

Never miss a story

Choose the plan that's right for you.
Digital access or digital and print delivery.